The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
The rise of digital transformation has resulted in a massive migration to the cloud. For Microsoft customers, migrating to the cloud involves running SQL Server and Windows Server workloads in Microsoft Azure. What You Will Learn In this eBook you will explore the...
Ensuring avionics software is reliable and safe is a top priority for aviation engineers. However, maintaining compliance throughout the software lifecycle is no simple task. Utilizing an ALM tool such as PTC’s Codebeamer can help ensure compliance with aviation...
According to Deloitte, 40% of the average engineer’s time is spent looking for information. This issue could be resolved with effective data management. Deciding which platform to store your organization’s data in can be difficult, as there are many great options on...
Introduction Welcome to this video from SPK and Associates. My name is Michael Roberts, VP of Sales and Marketing for SPK and Associates. Hi, I'm Chris McHale. I am co-founder and CEO of SPK and Associates, and we are an IT services company that focuses on...
